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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04151888
Other study ID # Epistaxis
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 30, 2020
Est. completion date June 30, 2021

Study information

Verified date November 2019
Source Assiut University
Contact Rania Tharwat Fahmi, Resident doctor
Phone 01013743663
Email raniatharwat93@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study was aimed to assess the efficacy and factors affecting the success of hot water irrigation in management of posterior epistaxis.


Description:

Epistaxis has been reported to occur in up to 60% of general population.This condition has incidence peaks at ages younger than 10 years and older than 50 years. Epistaxis appears to occur more in males than females . In rare cases massive nasal bleeding can lead to death.

Nasal bleeding usually responds to first aid measures such as compression.When Epistaxis doesn't respond to simple measures. The source of bleeding should be located and treated appropriately. Treatment options to be considered include topical vasoconstriction, chemical cautery, electrocautery, nasal packing, posterior gauze packing, use of balloon system, and arterial ligation or embolization. Hospital admission should be considered with patients with comorbid conditions or complication of blood loss.

Nasal Hot water irrigation was first described by Guice in 1878 as an effective method of treating severe life-threatening epistaxis. However, the technique was already in use by nineteenth century obstetricians as a method of treating postpartum bleeding . In the second half of the twenties century, nasal packing products and the development of endoscopic sinus surgery almost completely replaced the irrigation technique as treatment for posterior epistaxis. However, Stangerup et al. (1996) have demonstrated that hot water irrigation, using temperatures of up to 50°C, produces vasodilation and oedema of the nasal mucosa without the risk of necrosis and accelerating the clotting cascade.

Hot water irrigation had a higher success rate (55 %) in treating posterior epistaxis, compared with nasal packing (44 %) .Using a modified irrigation technique, was able to stop bleeding permanently in up to 82 %of cases of posterior epistaxis, including patients receiving antiplatelet agents or anticoagulants . During a follow-up period of four to 24 months. Furthermore, successful hot water irrigation was associated with less nasal trauma, significantly less pain, fewer surgical procedures and avoidance of a hospital stay.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date June 30, 2021
Est. primary completion date July 30, 2020
Accepts healthy volunteers No
Gender All
Age group 10 Years and older
Eligibility Inclusion Criteria:

- patients age: > 10 years.

- Failed first aid measures.

Exclusion Criteria:

- Patients age < 10 years old.

- Patients with anterior epistaxis.

- Patients presented with hemorrhagic shock.

- Patients presented with post-surgical bleeding.

- Suspected nasal pathology e.g tumors or trauma.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Foley catheter
Thin sterile tube will be inserted in choana

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (1)

Randall DA, Freeman SB. Management of anterior and posterior epistaxis. Am Fam Physician. 1991 Jun;43(6):2007-14. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of hot water irrigation in management of posterior epistaxis Observation of the patients for 24 hrs after controlling of posterior epistaxis using hot water irrigation if it can control posterior epistaxis or not and this will be confirmed by using coagulation profile and complete blood count 2 years
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